Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts tagged ‘iniparib’

Today’s Science Friday post looks at the identification of a potential new biomarker and possible strategies for expanding use of PARP inhibitors in patients most likely to respond to them as a way to validate the the approach prospectively.  This has important implications for future clinical trial designs with this class of drugs.

Photo Credit: Ben Sutherland via flickr

Photo Credit: Ben Sutherland via flickr

Regular readers will be very familiar at my rants against broad catch-all studies and phase III trials with targeted agents that do not have a biomarker or even a logical well defined subset of patients because it’s akin to blindfolding an archer, turning him around 360 degrees and then asking him to hit a bullseye 50 or 100 yards hence.

This weekend I’m heading off to Chicago for the annual meeting of the American Society of Clinical Oncology (ASCO).  I’ll be writing some in depth pieces and daily highlights from the conference, but in the meantime, many of you will be wondering what might be interesting amongst the 5,000 or so abstracts.

Here’s a quick snapshot of some data I’m looking forward to catching up on – there’s no clapperboard or guy with a teleprompter behind the camera, just a few ideas and some things to watch out for:


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Last week the American Society of Clinical Oncology (ASCO) held a press briefing to highlight some of the studies at the forthcoming annual meeting in Chicago next month.

ASCO Annual Meeting 2011 Patients, Progress, PathwaysASCO president, Dr George Sledge of Indiana, announced that the meeting theme for this year is “Patients, Pathways, Progress” to reflect the growing focus on molecular targets to identify and treat patients more effectively.

Traditionally, ASCO has organised their meeting around tumour types such as breast, lung, prostate and colon cancers, for example, but this year I was delighted to see that the Developmental Therapeutics section is getting more attention with a greater focus on the molecular targets that are now emerging:


A PSB reader wrote in asking whether an update on the PARP inhibitors and the clinical trials would be possible.   Following on from the last update in January that covered Sanofi’s negative iniparib phase III data in triple negative breast cancer and AstraZeneca’s decision in February not to pursue olaparib in hereditary BRCA1 and 2 positive breast cancers, it would be a good idea to see what’s left of this once highly promising class of compounds.

I first wrote about PARP inhibitors way back in 2006 and like many, I’m rather disappointed with the results we’ve seen so far.  However, all is not lost.  Abbott’s veliparib is going strong, while Pfizer (PF-01367338) and Cephalon (CEP-9722) are just getting started with their programs.


Now that the dust has settled on the news from sanofi-aventis yesterday that iniparib did not achieve it’s primary survival endpoints in the phase III trial in newly diagnosed triple negative breast cancer (TNBC), it’s time to take stock of this class.

Yesterday was another major snow shovelling day in New Jersey so I missed the AstraZeneca year end conference call.  A Pharma Strategy Blog reader kindly filled me in with some relevant information – the company discontinued the development of their PARP inhibitor, olaparib, in BRCA breast cancer – scroll down to the discontinued section to see the note.



That was the essence of an email alert that landed in my inbox from sanofi-aventis just now:

“A randomized Phase III trial evaluating BSI-201 (iniparib*) in patients with metastatic triple-negative breast cancer (mTNBC) did not meet the pre-specified criteria for significance for co-primary endpoints of overall survival and progression-free survival.”

After the brouhaha of the positive phase II data published in the NEJM the other week, this is another example of we should be careful getting over-excited by early data until confirmatory larger scale study results are available.


Iniparib phase II data in NEJM

At ESMO last summer the initial phase II trial data on a PARP inhibitor, iniparib (sanofi-aventis), was presented in triple negative breast cancer (TNBC). Unfortunately, I missed that session as it clashed with something else I wanted to see, but the data has now been published in the New England Journal of Medicine.

The references are provided below for the link to the online article and accompanying editorial (subscription required).

The front page of the journal provides a public link to the key overall survival data so far. As you can see, the bottom line is that the Kaplan-Meier curves do not cross over and a clear benefit in favour of the iniparib plus chemotherapy over chemotherapy alone is shown below:

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